As software and connectivity become integral to the modern healthcare ecosystem, medical device OEMs and their suppliers are pressured to comply with multiple security regulations, standards and internal policies. Fail to do so and you risk exposure to regulatory sanctions and brand equity erosion.
But current policy validation methodologies are unsustainable – they’re expensive because of a global shortage of skilled personnel and slow, due to a reliance on manual efforts.
Medical device manufacturers must transform to efficiently meet compliance demand and advance product security posture.
Cybellum enables OEMs and their suppliers to speed up and scale compliance validation and certification. Our Cyber Digital Twins™ platform provides the visibility, context and agility needed for reliable, expert-grade compliance validation.
Speed and Scale
Reduce manual efforts and automate compliance validation with MDRF WG/N60, FDA-2018-D-3443, MDCG 2019-16 and other regulations, standards and your own policies
Privacy and PII
Strengthen your privacy by exposing Personally Identifiable Information hiding in 1st and 3rd party software and comply with related regulations
Coding and Hardening
Validate adherence to your choice of software hardening mechanisms and secure development frameworks such as CERT C
Dashboards help you track your security score within and across development programs so you can advance your security posture and certification readiness
Expose and fix violations of your cryptographic guidelines such as insecure private key sharing, disapproved encryption/signing algorithms, encryption key length errors and more
Capture system and user activities such as changes to a vulnerability status or user triaging decisions, providing documented evidence in support of security auditing
The Cyber Digital Twins™ platform provides you the infrastructure to develop and maintain secure products at scale. It unifies pre-production Product Security Assessments with post-production Product Security Operations, providing you the visibility, context and agility needed to secure connected medical products across their lifespan. No source code needed.